Process Engineer | Scientist | Med-Tech

Process Engineer | Process Scientist |  Med-Tech | Brisbane 

We're supporting a cutting-edge med-tech company developing a new manufacturing process and looking for a Process Engineer | Process Scientist to play a key role in establishing and scaling this within a new environment. 

This is a hands-on role, working at the intersection of process development, engineering, and regulated manufacturing, supporting the delivery of a clinical-stage product.

The Role:

You will work closely with a multidisciplinary engineering team to:

• Support the qualification of a new cleanroom and manufacturing equipment
• Develop and validate aseptic manufacturing processes (including media fills)
• Contribute to the design, optimisation, and transfer of manufacturing processes
• Ensure processes meet PIC/S GMP and regulatory requirements
• Lead or support process troubleshooting, root cause analysis, and continuous improvement
• Assist in developing process documentation, protocols, and validation reports
• Work cross-functionally with engineering, quality, and operations teams

Experience required:

• Minimum 2-5 years' experience in process engineering / process development
• Background within pharmaceutical, medical device, or GMP-regulated environments
• Experience working with aseptic processes, cleanrooms, or regulated manufacturing
• Strong understanding of process validation, qualification (IQ/OQ/PQ), and GMP standards
• Hands-on mindset with the ability to work on the floor and solve real-world problems
• Strong communication skills and ability to work within cross-functional teams

Nice to Have:

• Experience with bio-manufacturing processes
• Exposure to scale-up or process transfer environments
• Experience in early-stage / R&D-led manufacturing environments

Why Join?

• Work on a globally significant biotech innovation
• Be part of a high-impact clinical programme
• Join a team building new manufacturing capability

This is a full-time, in-office position in Brisbane, with the opportunity for both full-time, permanent and a fixed term contract.